A Phase I Study of an Anti-KIR Antibody in Combination With an Anti-PD1 Antibody in Patients With Advanced Solid Tumors

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01714739 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-487


The purpose of this study is to assess the safety and tolerability of BMS-986015 given in combination with BMS-936558 and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination, in subjects with advanced (metastatic and/or unresectable) solid tumors.


Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Frank Stephen Hodi, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Daniel Cho, MD, Beth Israel Deaconess Medical Center
Donald Lawrence, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - During dose escalation, subjects with advanced solid tumors (except for primary CNS metastases) that have progressed following at least one standard regimen - During cohort expansion, subjects with non small cell lung cancer, melanoma, renal cell carcinoma, melanoma, colorectal, and ovarian cancer that have received at least one and no more than 5 prior treatment regimens - Subjects must have measurable disease - Subject must consent to provide previously collected tumor tissue - Women and men ≥ 18 years of age with performance status of 0 or 1 - At least 4 weeks since any previous treatment for cancer Exclusion Criteria: - Prior therapy with an immune cell modulating antibody except for anti-Cytotoxic T Lymphocyte Antigen 4 (CTLA4) - Active or chronic autoimmune diseases - Uncontrolled or significant cardiovascular disease - Chronic hepatitis - Active infection - Active Central nervous system (CNS) metastases
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